Maternal Immunization: US FDA Regulatory Considerations
Vaccination of pregnant women provides important health benefits to both mother and infant, and has been an important disease-prevention strategy in these two groups. However, since pregnant women are usually excluded from participation in clinical trials, conclusions regarding developmental risk for maternal vaccination are frequently based solely on data derived from developmental toxicity studies in animal models. This paper, published in Vaccine, reviews the regulatory, preclinical, and clinical issues specific to the United States Food and Drug Administration as they pertain to development programs for vaccines intended for use during pregnancy. ABSTRACT ONLY. (Learn how users in developing countries can gain free access to journal articles.)
Author(s): Gruber MF
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Citation: Gruber MF. Maternal Immunization: US FDA Regulatory Considerations. Vaccine. 2003;21(24):3487-3491.